WARNINGS
- Testim® should not be applied to the abdomen.
- Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatitis, hepatic neoplasms, cholestatic hepatitis, and jaundice). Peliosis hepatitis can be a life-threatening or fatal complication. Long-term therapy with testosterone enanthate, which elevates blood levels for prolonged periods has produced multiple hepatic adenomas. Transdermal testosterone is not known to produce these adverse effects.
- Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hyperplasia and prostatic carcinoma.
- Geriatric patients and other patients with clinical or demographic characteristics that are recognized to be associated with an increased risk of prostate cancer should be evaluated for the presence of prostate cancer prior to initiation of testosterone replacement therapy. In men receiving testosterone replacement therapy, surveillance for prostate cancer should be consistent with current practices for eugonadal men (see PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of Fertility and Laboratory Tests).
- Edema, with or without congestive heart failure, may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required.
- Gynecomastia occasionally develops and occasionally persists in patients being treated for hypogonadism.
- The treatment of hypogonadal men with testosterone may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases.
PRECAUTIONS
Transfer of testosterone to another person can occur when vigorous skin-to-skin contact is made with the application site (See Clinical Studies).
The following precautions are recommended to minimize potential transfer of testosterone from Testim®-treated skin to another person:
- Patients should wash their hands thoroughly and immediately with soap and water after application of Testim®. Studies of hand-washing show that Testim® is effectively removed from the skin surface by thorough washing with soap and water.
- Patients should cover the application site(s) with clothing after the gel has dried (e.g. a shirt).
- Prior to any situation in which direct skin-to-skin contact is anticipated, patients should wash the application sites thoroughly with soap and water so as to remove drug residue.
- In the event that unwashed or unclothed skin to which Testim® has been applied does come in direct contact with the skin of another person, the general area of contact on the other person should be washed thoroughly with soap and water as soon as possible.
Changes in body hair distribution, significant increase in acne, or other signs of virilization of the female partner should be brought to the attention of a physician.
General
The physician should instruct patients to report any of the following:
- Too frequent or persistent erections of the penis.
- Any changes in skin color, ankle swelling or unexplained nausea and vomiting.
- Breathing disturbances, including those associated with sleep.
Information for Patients
Advise patients to carefully read the information brochure that accompanies each carton of 30 Testim® single-use tubes.
Advise patients of the following:
- Testim® should not be applied to the scrotum, penis, or abdomen.
- Testim® should be applied once daily at approximately the same time each day to clean dry skin of the shoulders and/or upper arms.
- Washing or swimming may lessen testosterone levels; however, when washing occurs two or more hours post drug application, serum testosterone levels remain within the normal range.
- Testim® may be transferred to another person by vigorous contact with the application site. Potential for transfer may be reduced by washing hands thoroughly after application, by wearing clothing to cover the sites, and by washing the application sites thoroughly with soap and water prior to any direct skin-to-skin contact.
Laboratory Tests
- Hemoglobin and hematocrit levels should be checked periodically (to detect polycythemia) in patients on long-term androgen therapy.
- Liver function, prostate specific antigen (PSA), cholesterol, and high-density lipoprotein (HDL) should be checked periodically.
- To ensure proper dosing, serum testosterone concentrations should be measured (see DOSAGE AND ADMINISTRATION).
Drug Interactions
Oxyphenbutazone: Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone.
Insulin: In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.
Propranolol: In a published pharmacokinetic study of an injectable testosterone product, administration of testosterone cypionate led to an increased clearance of propranolol in the majority of men tested. It is unknown if this would apply to Testim®.
Corticosteroids: The concurrent administration of testosterone with ACTH or corticosteroids may enhance edema formation; thus these drugs should be administered cautiously, particularly in patients with cardiac or hepatic disease.
Drug/Laboratory Test Interactions
Androgens may decrease levels of thyroxin-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Animal Data
Testosterone has been tested by subcutaneous injection and implantation in mice and rats. In mice, the implant induced cervical-uterine tumors, which metastasized in some cases. There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically induced carcinomas of the liver in rats.
Human Data
There are rare reports of hepatocellular carcinoma in patients receiving long-term oral therapy with androgens in high doses. Withdrawal of the drugs did not lead to regression of the tumors in all cases.
Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hyperplasia and prostatic carcinoma. Geriatric patients and other patients with clinical or demographic characteristics that are recognized to be associated with an increased risk of prostate cancer should be evaluated for the presence of prostate cancer prior to initiation of testosterone replacement therapy.
In men receiving testosterone replacement therapy, surveillance for prostate cancer should be consistent with current practices for eugonadal men.
Pregnancy Category X (see Contraindications) - Teratogenic Effects
Testim® is not indicated for women and must not be used in women. Testosterone may cause fetal harm.
Nursing Mothers
Testim® is not indicated for women and must not be used in nursing mothers.
Pediatric Use
Safety and efficacy of Testim® in patients <18 years old has not been established.
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